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| ID | Type | Description | Link |
|---|---|---|---|
| DJCLS R 13/23 | Other Grant/Funding Number | Deutsche José Carreras Leukämie-Stiftung (DJCLS) |
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| Name | Class |
|---|---|
| Deutsche José Carreras Leukämie-Stiftung (DJCLS) | UNKNOWN |
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Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes is evaluated. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.
Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes such as depression, fatigue, health-related quality of life and physical fitness is evaluated. A healthy control group matched to the patients on age, gender, and education will be included to both control for practice effects on neuropsychological measures and allow additional comparisons on self-report measures. The healthy control group will undergo neuropsychological testing and questionnaire survey at baseline and 4 months. Demographic data will be collected from all study participants at baseline. Medical data will be collected from patients at all time points. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study. |
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| Control group | Other | A waitlist control group will get the intervention after 7 month of treatment as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive functioning as assessed by Change in total z-score | Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London). | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive functioning as assessed by Change in total z-score | Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London). | Baseline and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intentional behaviour related to physical activity | Measured with the stage of change component of the transtheoretical model | 4 months, 7 months |
| Self-efficacy towards physical exercise | Measured with three items (Fuchs, 2008) |
Patients:
Inclusion Criteria:
Exclusion Criteria:
Healthy controls (matched for age, gender, and education):
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Scherwath, Dr. phil. | Contact | +49(40) 7410- 57565 | a.scherwath@uke.de | |
| Karl-Heinz Schulz, Prof.Dr.Dr. | Contact | +49(40) 7410- 54132 | khschulz@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Schulz, Prof.Dr.Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Control | Behavioral | A waitlist control group will get the intervention after 7 month of treatment as usual. |
|
| Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires | Change in scale sum score of the FEDA and FLei questionnaires measuring self-perceived attentional (FEDA scale 1: Distractibility and Retardation in Mental Processes, FEDA scale 2: Fatigue and Retardation in Activities of Daily Living, FEDA scale 3: Decrease in Drive), memory (FLei scale memory), and executive dysfunctions (FLei scale executive function). | Baseline, 4 months, 7 months |
| Change in fine-motor function | Change in z-score derived from the GPT dominant hand | Baseline, 4 months, 7 months |
| Change in physical fitness (muscle strength) | Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value) | Baseline, 4 months, 7 months |
| Change in physical ability/capability (walking ability) | Measured with the 6-min walk test (change in walk distance in meters) | Baseline, 4 months, 7 months |
| Change in physical activity (intensity) | Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values) | Baseline, 7 months |
| Change in self-reported physical activity | Measured with the EPIC Physical Activity Questionnaire | Baseline, 4 months, 7 months |
| Change in immunological functions | Severity of GvHD | Baseline, 4 months, 7 months |
| Change in health-related quality of life | Measured with the EORTC QLQ-C30 (change in global health status / QoL scale) | Baseline, 4 months, 7 months |
| Change in fatigue | Measured with the MFI-20 (change in total score) | Baseline, 4 months, 7 months |
| Change in anxiety | Measured with the HADS subscale anxiety (change in subscale score) | Baseline, 4 months, 7 months |
| Change in depressive symptoms | Measured with the HADS subscale depression (change in subscale score) | Baseline, 4 months, 7 months |
| Change in fear of cancer recurrence | Measured with the PA-F12 (change in sum score) | Baseline, 4 months, 7 months |
| 4 months, 7 months |
| Situational barriers for physical exercise | Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010) | 4 months, 7 months |
| Grip strength | Measured with a handgrip dynamometer | Baseline, 4 months, 7 months |
| Inflammation | High-sensitivity CRP derived from routine blood samples | Baseline, 4 months, 7 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |